Classification-Directed Treatment of Low Back Pain
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Low Back Pain
- Sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Enrollment
- 101
- Locations
- 1
- Primary Endpoint
- Modified Oswestry Disability Index for Low Back Pain (0-100%)
- Status
- Completed
- Last Updated
- 13 years ago
Overview
Brief Summary
The primary purpose of this proposal is to conduct a prospective, randomized, controlled clinical trial to examine whether or not treatment based on a person's direction-specific, impairment-based LBP classification is more effective than Non-specific treatment in improving short- (6 weeks) and long-term (6 and 12 months) outcomes in people with chronic LBP. We hypothesize that treatment based on a person's direction-specific, impairment-based LBP classification (Classification-specific) will result in better outcomes than Non-specific treatment. Our approach to classification-directed treatment is based on the proposal that a person's LBP is the result of adopting direction-specific strategies of movement and alignment of the spine which then are used repeatedly during the person's everyday activities. The exposure of spine tissue to repeated loading in the same direction across a day is proposed to accelerate the accumulation of stress, microtrauma, and eventually LBP. We also hypothesize that until the factors contributing to the use of the direction-specific strategies of the spine are modified, the LBP problem will persist or recur. Identification of homogeneous subgroups of people with LBP will enhance 1) the power of clinical trials, 2) prognosis, and 3) the ability to identify mechanisms contributing to different LBP problems.
Investigators
Linda Van Dillen
Associate Professor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Eligibility Criteria
Inclusion Criteria
- •People who report a history of chronic LBP for a minimum of 12 months,currently are experiencing LBP symptoms but not in an acute recurrence,
- •Between 18 and 60 years of age,
- •Able to stand and walk without assistance,
- •Able to understand and read English,
- •Able to understand and sign a consent form
Exclusion Criteria
- •Any structural spinal deformity including scoliosis, kyphosis, or stenosis,
- •A spinal fracture or dislocation,
- •Osteoporosis,
- •Ankylosing spondylitis,
- •Rheumatoid arthritis,
- •Disc herniation,
- •Serious spinal complications such as tumor or infection,
- •Previous spinal surgery,
- •Frank neurological loss, i.e., weakness and sensory loss,
- •Pain or paresthesia below the knee,
Outcomes
Primary Outcomes
Modified Oswestry Disability Index for Low Back Pain (0-100%)
Time Frame: Baseline, completion of treatment phase, 6 months after treatment phase,12 months after treatment phase
Functional limitation measure
Secondary Outcomes
- SF-36 Bodily Pain subscale (0-100%)(Baseline, completion of treatment phase, 6 months after treatment phase,12 months after treatment phase)
- Kinematic measures of select movements and postures(Baseline, completion of treatment phase)
- Medication use (yes, no)(Baseline, completion of treatment phase, 6 months after treatment phase,12 months after treatment phase)
- Fear Avoidance Beliefs Questionnaire Work subscale (0-42 points)(Baseline, completion of treatment phase, 6 months after treatment phase,12 months after treatment phase)
- Numeric pain rating scale (0-10 points)(Baseline, completion of treatment phase, 6 months after treatment phase,12 months after treatment phase)
- SF-36 Role Functioning-Emotional subscale (0-100%)(Baseline, completion of treatment phase, 6 months, 12 months)
- Days of low back pain-related time off (number)(Baseline, 6 months after treatment phase, 12 months after treatment phase)
- SF-36 Physical Functioning subscale (0-100%)(Baseline, completion of treatment phase, 6 months after treatment phase,12 months after treatment phase)
- SF-36 Role Functioning-Physical subscale (0-100%)(Baseline, completion of treatment phase, 6 months after treatment phase,12 months after treatment phase)
- SF-36 Social Functioning Subscale (0-100%)(Baseline, completion of treatment phase, 6 months after treatment phase,12 months after treatment phase)
- Adherence to exercise (0-100%)(Second treatment visit, completion of treatment phase, 6 months after treatment phase, 12 months after treatment phase)
- Baecke Habitual Activity Measure (3-15 points)(Baseline, completion of treatment phase, 6 months after treatment phase,12 months after treatment phase)
- SF-36 Role Functioning subscale (0-100%)(Baseline, completion of treatment phase, 6 months after treatment phase,12 months after treatment phase)
- SF-36 General Health subscale (0-100%)(Baseline, completion of treatment phase, 6 months after treatment phase,12 months after treatment phase)
- SF-36 Vitality subscale (0-100%)(Baseline, completion of treatment phase, 6 months after treatment phase,12 months after treatment phase)
- Fear Avoidance Beliefs Activity subscale (0-24 points)(Baseline, completion of treatment phase, 6 months after treatment phase,12 months after treatment phase)
- SF-36 Mental Health subscale (0-100%)(Baseline, completion of treatment phase, 6 months after treatment phase,12 months after treatment phase)
- Adherence to training in performance of functional activities (0-100%)(Second treatment visit, completion of treatment phase, 6 months post-treatment phase, 12 months post-treatment phase)